Head and Neck CancerNCT02662907
Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy
A study testing Barium Swallow, Questionnaires and Expiratory Muscle Strength Training (EMST) Device in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if exercising the muscles that help you cough and swallow, called expiratory muscle strength training (EMST), can help reduce the risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients who have had radiation for head and neck… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Barium Swallow, Questionnaires and Expiratory Muscle Strength Training (EMST) Device
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- History of curative-intent radiotherapy at MDACC for a new primary H\&N cancer in past 15 years
- Referred to Section of Speech Pathology and Audiology for swallowing evaluation
- Ability to understand and willingness to sign written informed consent
Who cannot join
- History of recurrent or second primary H\&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study
- Prior H\&N surgery excluding diagnostic procedures, transoral surgery, or non-radical neck dissection
- History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular disease
- Tracheotomy or oxygen dependence at time of MBS
- Patients with Mini-Mental State Examination (MMSE) <24 will be ineligible for participation in the therapeutic trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if exercising the muscles that help you cough and swallow, called expiratory muscle strength training (EMST), can help reduce the risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients who have had radiation for head and neck cancer.
Read the detailed description
Study Visits:
If you are found to be eligible and you agree to take part in the therapeutic portion of the EMST therapy study, you will be trained how to use the EMST device. This device is designed to help strengthen the muscles used for swallowing and coughing. To use this small handheld device, you will wear a nose clip to prevent air from coming out of your nose. You will be asked to sit upright and take a deep breath, hold your breath for a moment, and then blow forcefully into the device until you break the seal.
You will use the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks. Using the EMST device should take about 15 minutes each day you train.
One (1) time each week during these 8 weeks, you will meet with a speech pathologist in the Head and Neck Center at MD Anderson. At each visit, you will use the digital manometer to re-test how forcefully you are able to exhale and cough. The resistance of the EMST device will be adjusted based on each week's measurement.
Length of Study:
You will be on study for up to 12 months. Your study participation will be over after the follow-up call, described below. You will be taken off study early if you are unable to use the EMST device, if the doctor thinks it is in your best interest, or if you are unable to follow study directions.
Follow-Up Visit:
After 8 weeks of using the EMST device, you will have a follow-up visit.
- You will have the same functional testing you had at screening (the modified barium swallow and tests of your tongue strength, mouth opening, and ability to exhale and cough forcefully).
- You will complete the questionnaires and will be asked about your symptoms and quality of life.
Follow-Up Call:
You will be contacted by phone 12 months after you joined the study to complete 4 questionnaires about your symptoms, health and quality of life. This call should take up to 15 minutes.
This is an investigational study. The EMST device is FDA approved for exercising the muscles used in coughing and swallowing. Its use in preventing aspiration in patients who have received radiation for head and neck cancer is considered investigational.
Up to 300 patients will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Barium Swallow, Questionnaires, Expiratory Muscle Strength Training (EMST) Device, Digital Manometer, Neurocognitive Exams
- Keywords
- Head and Neck Cancer, Post-radiotherapy H&N cancer survivors, Aspiration, Expiratory muscle strength training, EMST, Dysphagia therapy, Modified barium swallow, Neurocognitive exams, Questionnaires, Surveys, Digital Manometer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barium SwallowProcedure or surgery
Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study.
Expiratory Muscle Strength Training (EMST) DeviceDevice
Also called EMST
Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks.
Digital ManometerDevice
Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device.
Neurocognitive ExamsBehavioural
Participants given neurocognitive exams at baseline.
BariumDrug
Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.
| Study group | Role | What they receive |
|---|---|---|
| Aspirators Group | Experimental | Participants receive modified barium swallow at baseline and after 8 weeks of using the expiratory muscle strength training (EMST) device. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study.
Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks.
Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device. Receives: Procedure: Barium Swallow; Behavioral: Questionnaires; Device: Expiratory Muscle Strength Training (EMST) Device; Device: Digital Manometer; Behavioral: Neurocognitive Exams; Drug: Barium |
| Non-Aspirators Group | Other | Participants receive modified barium swallow at baseline. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline and at 12 months. Receives: Procedure: Barium Swallow; Behavioral: Questionnaires; Behavioral: Neurocognitive Exams; Drug: Barium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Aspiration and Expiratory Function Using Expiratory Training in Post-Radiotherapy H&N Cancer Survivors
Primary analysis is association between baseline Penetration-Aspiration Scale (PAS) scores and baseline maximum expiratory pressures (MEPs). Analysis examined by plotting the data and computing a polyserial correlation coefficient. Participants with PAS≥6 coded as aspirators.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start1 Feb 2016
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- IRG
- Responsible party
- Sponsor
- Investigators
- Katherine A. Hutcheson, PHD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662907
- Sponsor's protocol ID
- 2015-0238
- Other IDs
- NCI-2016-00174
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2016
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy
- ClinicalTrials.gov ID
- NCT02662907
- Acronym / sponsor ID
- 2015-0238
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Post-radiotherapy H&N cancer survivors, Aspiration, Expiratory muscle strength training, EMST, Dysphagia therapy, Modified barium swallow, Neurocognitive exams
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- IRG
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if exercising the muscles that help you cough and swallow, called expiratory muscle strength training (EMST), can help reduce the risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients who have had radiation for head and neck cancer.
Detailed description
Study Visits:
If you are found to be eligible and you agree to take part in the therapeutic portion of the EMST therapy study, you will be trained how to use the EMST device. This device is designed to help strengthen the muscles used for swallowing and coughing. To use this small handheld device, you will wear a nose clip to prevent air from coming out of your nose. You will be asked to sit upright and take a deep breath, hold your breath for a moment, and then blow forcefully into the device until you break the seal.
You will use the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks. Using the EMST device should take about 15 minutes each day you train.
One (1) time each week during these 8 weeks, you will meet with a speech pathologist in the Head and Neck Center at MD Anderson. At each visit, you will use the digital manometer to re-test how forcefully you are able to exhale and cough. The resistance of the EMST device will be adjusted based on each week's measurement.
Length of Study:
You will be on study for up to 12 months. Your study participation will be over after the follow-up call, described below. You will be taken off study early if you are unable to use the EMST device, if the doctor thinks it is in your best interest, or if you are unable to follow study directions.
Follow-Up Visit:
After 8 weeks of using the EMST device, you will have a follow-up visit.
- You will have the same functional testing you had at screening (the modified barium swallow and tests of your tongue strength, mouth opening, and ability to exhale and cough forcefully).
- You will complete the questionnaires and will be asked about your symptoms and quality of life.
Follow-Up Call:
You will be contacted by phone 12 months after you joined the study to complete 4 questionnaires about your symptoms, health and quality of life. This call should take up to 15 minutes.
This is an investigational study. The EMST device is FDA approved for exercising the muscles used in coughing and swallowing. Its use in preventing aspiration in patients who have received radiation for head and neck cancer is considered investigational.
Up to 300 patients will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirators Group | Experimental | Procedure: Barium Swallow, Behavioral: Questionnaires, Device: Expiratory Muscle Strength Training (EMST) Device, Device: Digital Manometer, Behavioral: Neurocognitive Exams, Drug: BariumParticipants receive modified barium swallow at baseline and after 8 weeks of using the expiratory muscle strength training (EMST) device. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study. Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks. Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device. |
| Non-Aspirators Group | Other | Procedure: Barium Swallow, Behavioral: Questionnaires, Behavioral: Neurocognitive Exams, Drug: BariumParticipants receive modified barium swallow at baseline. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline and at 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >/= 18 years
- History of curative-intent radiotherapy at MDACC for a new primary H\&N cancer in past 15 years
- Referred to Section of Speech Pathology and Audiology for swallowing evaluation
- Ability to understand and willingness to sign written informed consent
Key exclusion criteria (5 listed)
- History of recurrent or second primary H\&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study
- Prior H\&N surgery excluding diagnostic procedures, transoral surgery, or non-radical neck dissection
- History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular disease
- Tracheotomy or oxygen dependence at time of MBS
- Patients with Mini-Mental State Examination (MMSE) <24 will be ineligible for participation in the therapeutic trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barium SwallowParticipants receive modified barium swallow at baseline and after 8 weeks of using the EMST device | Procedure or surgery | Aspirators Group, Non-Aspirators Group |
| QuestionnairesAlso: SurveysQuestionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study. | Behavioural | Aspirators Group, Non-Aspirators Group |
| Expiratory Muscle Strength Training (EMST) DeviceAlso: EMSTParticipant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks. | Device | Aspirators Group |
| Digital ManometerDigital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device. | Device | Aspirators Group |
| Neurocognitive ExamsParticipants given neurocognitive exams at baseline. | Behavioural | Aspirators Group, Non-Aspirators Group |
| BariumParticipants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device. | Drug | Aspirators Group, Non-Aspirators Group |
Primary outcome
Association Between Aspiration and Expiratory Function Using Expiratory Training in Post-Radiotherapy H&N Cancer Survivors
Time frame: 12 months
Primary analysis is association between baseline Penetration-Aspiration Scale (PAS) scores and baseline maximum expiratory pressures (MEPs). Analysis examined by plotting the data and computing a polyserial correlation coefficient. Participants with PAS≥6 coded as aspirators.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A. Hutcheson, PHD, MS, BA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barium Swallow, Questionnaires and Expiratory Muscle Strength Training (EMST) Device in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Aspiration and Expiratory Function Using Expiratory Training in Post-Radiotherapy H&N Cancer Survivors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.